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    Home > Medical News > Latest Medical News > Shanghai and Huangyao Danning tablets are approved to be certified by overseas production sites in Canada

    Shanghai and Huangyao Danning tablets are approved to be certified by overseas production sites in Canada

    • Last Update: 2019-09-29
    • Source: Internet
    • Author: User
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    September 29, 2019 / AP / -- recently, Shanghai and Huangyao Danning tablet officially obtained the approval document of production site certification (FSRN: 5000525) outside Canada From July 12, 2019, the company was approved to be certified as an overseas production site in Canada (FSRN: 5000525) and officially received the approval, after two months of publicity period Shanghai and Huangyao Pharmaceutical Co., Ltd took the lead in becoming a Chinese medicine manufacturer with FSRN certificate issued by the Ministry of health of Canada They independently hold the Canadian natural medicine listing license and overseas production qualification Since the establishment of Danning tablet in 2001, Shanghai Hehuang Pharmaceutical Co., Ltd has established the development strategy of modernization and internationalization of traditional Chinese medicine The modern research results of the company's key products, Shexiang Baoxin Pill, have successively won the "first prize of Shanghai Science and technology progress" in 2011 and the "second prize of national science and technology progress" in 2018, becoming a successful model for the modernization research of traditional Chinese medicine and the second development of large varieties of traditional Chinese medicine in China Danning tablet, another key product of the company, started international registration in Canada since 2014, and obtained the listing license of natural drugs in Canada (NPN: 80073325, trade name: biliflow) in December 2016 and July 2019, respectively, and the certification of overseas production sites in Canada, becoming one of the successful models of internationalization of Chinese medicine In recent years, with the support of Shanghai Science and Technology Commission and other relevant units, Shanghai Hehuang Pharmaceutical Co., Ltd has carried out continuous research on the modernization and innovation of traditional Chinese medicine around Danning tablet Shanghai Hehuang Pharmaceutical Co., Ltd has provided nearly 100 registration application materials to the Ministry of health of Canada, most of which are modern and innovative research results The successful registration of Danning tablets in the Canadian market also benefits from this In this stage, Shanghai Hehuang Pharmaceutical Co., Ltd successfully formulated the international standard of Danning tablet, and achieved the improvement based on the standard of Chinese Pharmacopoeia, including the improvement of qualitative detection index, the establishment of quantitative detection index content range, the establishment of heavy metal and agricultural residue index, the increase of microbial index and the establishment of indicators to ensure the consistency of product quality The approval of the overseas production site certification of Danning tablet benefits from the establishment of the company's quality control system for the whole product chain of Danning tablet and the implementation of good production quality management standards More than 180 certification application materials provided by Shanghai Hehuang Pharmaceutical Co., Ltd to the Ministry of health of Canada reflect the company's perfect daily production management system and good implementation level of GMP in China, and better achieve the docking with international pharmaceutical production quality management standards The important significance of the successful registration of Danning tablet in Canada is to explore a feasible path for the large compound traditional Chinese medicine preparation, which embodies the theory of traditional Chinese medicine, to go to the international market in a legal way The core of this path is the recognition of the foreign drug evaluation departments on the basic research, clinical evaluation and other modern research evidence of traditional Chinese medicine in China This is a feasible path suitable for the current situation and reality of Chinese medicine industry This path can open up a broad space for the internationalization of Chinese medicine, which is worthy of reference and promotion in Chinese medicine industry, and has an important demonstration significance Danning tablet originated from the prescriptions of Professor Gu Bohua and Professor Xu Changsheng of Longhua Hospital It was jointly developed and developed by Professor Zhu Peiting and Shanghai No.1 pharmaceutical factory of traditional Chinese medicine after eight years It has the functions of soothing the liver, benefiting the gall and clearing away heat It has become a national class three new drug In December 2016, Danning tablet was approved by the Canadian natural medicine marketing license and became a compound Chinese patent medicine fully recognized by the Health Ministry of Canada as "functional indications" In July 2019, Shanghai Hehuang Pharmaceutical Co., Ltd was approved as an overseas production site certification (FSRN) in Canada, becoming the first Chinese medicine manufacturer in China to obtain the FSRN certificate issued by the Ministry of health of Canada Source: Shanghai Hehuang Pharmaceutical Co., Ltd
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